Oxford-AstraZeneca pauses pediatric trial pending review by UK regulator

The spokesperson said the trial in children had not raised any safety concerns, but would be halted while Britain’s Medicines and Healthcare Products Regulatory Agency, or MHRA, reviews rare cases of people suffering from blood clots and at the same time. time, they have low blood levels. platelets.

“Parents and children should continue to attend all scheduled visits and can contact the testing sites if they have any questions,” the spokesperson said.

When contacted by CNN, AstraZeneca referred inquiries to the University of Oxford.

Last week, the drug regulator said that at least 30 people in the country had experienced rare types of blood clots after receiving the vaccine, but warned it was too early to know whether the injection itself triggered the clots.

MHRA Director Dr June Raine told CNN on Tuesday that the MHRA was “aware of the decision made by Oxford University to pause dosing in the trial … while the safety review of the MHRA is ongoing. “

“The safety of participants in any clinical trial is our highest priority and no safety issues have been reported with this trial,” he added.

Here's what you need to know about the risk of blood clots and the AstraZeneca vaccine

MHRA said in a statement that it received 22 reports of cerebral venous sinus thrombosis (CVST), where clotting forms in the sinuses that drain blood from the brain, and another eight reports of thrombosis among a total of 15.8 million people a those who had received at least one dose of the vaccine before March 21.

They did not say how many blood clots might have otherwise been expected among 15.8 million people.

The agency has advised the UK to continue to administer the vaccine in all groups, arguing that such clotting incidents are very rare and that the benefits still greatly outweigh the risks, echoing similar assessments by the European Medicines Agency ( EMA) and the World Health Organization (WHO).

Regulators in other countries have also reported blood clots among people who have received the vaccine, particularly in Europe, where the AstraZeneca vaccine is widely used. Some countries are choosing to discontinue the vaccine altogether, while others have limited its use to certain age groups.

Blood clots in general are so common that a certain number of people are expected to contract them for various reasons on any given day of a given week. If someone has received a vaccine and then develops a blood clot, it does not necessarily mean that the injection caused the clot.

After initial reports of clotting last month, AstraZeneca was quick to point out that the incidence of clots in general is lower in people who have received the injection than in the general population.

An AstraZeneca spokesperson said in a statement to CNN last week: “Patient safety remains the company’s top priority,” pointing to UK, EU and WHO authorities to continue its use. .

“The risk-benefit profile of the vaccine was reaffirmed in the EMA’s monthly safety update,” the spokesperson said.

CNN’s Angela Dewan and Richard Allen Greene contributed to this report.


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